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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number 1107-36
Medical Device Problem Code Failure to Capture (1081)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
It was reported that the implantable cardioverter defibrillator exhibited loss of capture.The device was successfully explanted and replaced.The patient was stable.
 
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
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Brand Name
CURRENT VR
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key7767839
Report Number2017865-2018-11583
Device Sequence Number2076662
Product Code LWS
UDI-Device Identifier05414734502184
UDI-Public05414734502184
Combination Product (Y/N)N
Initial Reporter CountryCH
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/30/2015
Device Model Number1107-36
Device Lot Number4636520
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 08/05/2018
Supplement Date Received by Manufacturer01/28/2019
03/05/2019
Initial Report FDA Received Date08/09/2018
Supplement Report FDA Received Date01/30/2019
03/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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